Kornimate/medical-research-clean huggingface dataset:
assessment of patient use of a new device: rebismart

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms) is a chronic disease which causes inflammation and destruction of the nerves in within the brain and the spinal cord. this disease is one of the most common causes of disability in young adults. a ''relapse'' is a phenomenon that occurs when there is an acute attack of disability as a result of an acute attack on the nervous system. there is usually some degree of recovery after a relapse. rebif is licensed in the united kingdom for the treatment of relapsing ms and is given 3 times a week by injections under the skin. the rebismart device is a new injection device which has been developed to help patients with injecting their rebif treatment. currently, all treatments for ms are injectable and require long term patient commitment. patient compliance to treatment is important for the therapy to work effectively and decrease the risk of relapse episodes. using a device that makes it easy for patients to inject may potentially improve compliance to treatment and therefore potentially have an impact on the number of relapses patients experience. the rebismart device has been developed for patients to inject conveniently and in comfort. the device allows the patient to control certain parameters such as needle depth, needle speed, injection time etc, and also has extra features designed to ease the injection process, such as a dose history calendar and an on-screen injection guide. the aim of this study is to determine what percentage of patients liked using the rebismart device and found it ''easy'' or ''very easy'' to use. the study will also determine which of the device features were most useful to the patients.


Eligibility criteria:
inclusion criteria: * have relapsing remitting multiple sclerosis * between 18 to 65 years old inclusive * have been prescribed rebif for the first time but not yet started treatment * rebismart as chosen device * be under review by ms nurse * having given written informed consent to participate in the study exclusion criteria: * injections of rebif given by someone other than the patient * patients unable to use the rebismart device due to visual or physical impairment * patients unwilling to give informed consent * contra-indications to rebif as defined in the summary of product characteristics (spc). * allergy to the antipyretic analgesics that will be advised as prophylaxis for flu-like symptoms

Keywords: multiple sclerosis rebif interferon beta-1a
prevention of low blood pressure in persons with tetraplegia

Conditions: Hypotension; Spinal Cord Injury

Summary: the aim of this investigation is to determine the blood pressure response to nos inhibition, with l-name, in persons with tetraplegia compared to non-sci control subjects and to establish if blood pressure can be increased while upright in those with tetraplegia. if blood pressure is increased with nos inhibition in persons with tetraplegia, this would improve our treatment of the condition of low blood pressure during seated postures in individuals with tetraplegia.

despite disruption of central command of the vasculature during orthostatic maneuvers, individuals with tetraplegia are generally able to be seated in an upright position for long periods of time without developing symptoms of orthostatic intolerance. it must be appreciated however, that orthostatic hypotension may occur unpredictably in persons with chronic tetraplegia. this may result in a range of symptoms due to cerebral hypoperfusion from mild reduction in mental acuity to loss of consciousness. nitric oxide (no) is the most potent endogenous vasodilator which is synthesized by the enzyme no synthase (nos) and may be largely responsible for orthostatic hypotension in individuals with immobilizing conditions. recent evidence suggests an up-regulation of inducible nitric oxide synthases (nos) activity with prolonged exposure to hind limb suspension. the effects of nos inhibition during orthostasis on blood pressure regulation in those with chronic tetraplegia may provide insight into effective pharmacological therapy to reduce or prevent pathologic orthostatic changes. treatment with a nos inhibitor may facilitate the process of mobilization in those with acute higher cord lesions.

Eligibility criteria:
inclusion criteria: * 18 to 65 year olds. * non-ambulatory chronic tetraplegia (1 year after acute sci). exclusion criteria: * central nervous system disease (other than sci) e.g., multiple sclerosis, amyotrophic lateral sclerosis, syringomyelia, tabes dorsalis; * peripheral neuropathies; * surgical sympathectomy; * coronary heart and/or artery disease; * anemia; * hypertension; * renal function abnormalities; * diabetes mellitus; * pituitary insufficiency; * adrenal insufficiency; * hypothyroidism; and * medications known to affect the cardiovascular system.

Keywords: blood pressure cardiovascular autonomic control nitric oxide nos inhibitor orthostatic hypotension spinal cord injury tetraplegia
weight loss study-mechanism underlying the improvement of insulin resistance in response to weight loss

Conditions: Obesity; Weight Loss

Summary: the main purpose of this study is to assess factors mediating the changes in insulin sensitivity and glucose tolerance before and after 10 lbs ± or 2% weight loss reduction as well as 2, 3, 6, 12, and 24 months after initiation of a low calorie diet. the investigators will also study the following: 1. the impact of diet induced weight loss on hormones/adipokine levels 2. the impact of diet induced weight loss on leptin tolerance


Eligibility criteria:
inclusion criteria for interventional group: 1. adult men and women, age 18-50 2. english speaking 3. body mass index (pre weight loss) ≥30 kg/m2 but \<40 kg/m2 4. willing to enroll in a low calorie full meal replacement weight loss program 5. willing and able to take part in a multi year study involving visits inclusion criteria for control group: 1. adult men and women, age 18-50 2. english speaking 3. body mass index (pre weight loss) ≥30 kg/m2 but \<40 kg/m2 4. willing and able to take part in a multi year study involving visits

Keywords: overweight obesity obese weight loss
a study to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of biib054 in japanese participants with parkinson's disease

Conditions: Parkinson's Disease

Summary: the primary objective of this study is to evaluate the safety and tolerability of a range of single and 13 repeated doses of biib054, administered as intravenous (iv) infusion, in japanese participants with parkinson's disease (pd). the secondary objectives are to evaluate the immunogenicity, and serum pharmacokinetics (pk) profile of biib054 after single and multiple dose administration.


Eligibility criteria:
key inclusion criteria: * diagnosed with pd within a maximum of 3 years prior to screening. * has not received levodopa or any other treatment for pd, herein referred to as symptomatic pd medication (including but, not limited to, dopamine agonists, amantadine, anticholinergics, monoamine oxidase type b (mao-b) inhibitors, or safinamide) for at least 12 weeks prior to day 1. maximum total duration of prior pd regimens should not exceed 30 days. * score of less than equal to (\<=) 2.5 on the modified hoehn and yahr scale. * screening dopamine transporter (dat)/ single-photon emission computed tomography (spect) results consistent with neurodegenerative parkinsonism (central reader). key exclusion criteria: * presence of freezing of gait. * history of or positive test result at screening for human immunodeficiency virus (hiv) or hepatitis c virus antibody (anti-hcv). * screening value for hemoglobin less than (\<)12 gram per deciliter (g/dl) for men or \<11 g/dl for women. * montreal cognitive assessment (moca) score \<23 or other significant cognitive impairment or clinical dementia. * history of any brain surgery for pd. * participation in any passive or active immunotherapy targeting alpha-synuclein or other pd-related protein. note: other protocol defined inclusion/exclusion criteria may apply.
tapentadol vs tramadol in total knee arthroplasty

Conditions: Total Knee Replacement; Post-operative Pain; Chronic Pain

Summary: compare the effectiveness of tapentadol and tramadol as part of a multimodal analgesia treatment for total knee replacement (tkr).

as the population ages and becomes more active, the demand for tkr surgery is expected to increase. however, the treatment of tkr pain remains a challenge. postoperative pain is associated with longer hospital stays, lower satisfaction, increased opioid consumption, and transition to chronic pain. in tkr, the risk of chronic pain can be as high as 20%. a suggested method of anesthesia and pain relief is the use of spinal anesthesia along with multimodal analgesia that includes an adductor canal block. in our hospital, the multimodal analgesia protocol consists of intraoperative sedation with dexmedetomidine, a low dose of ketamine, paracetamol, nsaids, and magnesium. dexamethasone and droperidol are preferred as antiemetics as they can improve the analgesic outcome. to minimize the use of opioids, the administration of tramadol used to be the standard of care. tapentadol is an opioid that can be equally effective in the treatment of postoperative pain and reduces the incidence of chronic pain after tkr.

Eligibility criteria:
inclusion criteria: * patients for elective tkr * asa ps i - iii exclusion criteria: * patient refusal * cognitive disfunction * severe psychiatric disease * under medication with mao inhibitors, tricyclic antidepressants, serotonin reuptake inhibitors * not speaking greek * known allergy to the study drugs * contraindications for any of the study drugs * chronic renal failure (gfr \< 50 ml/h) * liver failure * known regular use or misuse of opioids * pregnant women * patients undergoing general anesthesia

Keywords: total knee replacement post-operative pain tramadol tapentadol
exercise in prevention of metabolic syndrome

Conditions: Metabolic Syndrome

Summary: the primary objective of the study is to compare in a real-world setting the efficacy of traditional training (today's guideline, vigorously or moderate exercise) and amount of aerobic interval training (1-ait) in reduction of risk factors constituting metabolic syndrome. the secondary objective is to compare the efficacy of traditional moderate training (today's guideline) and amount of aerobic interval training (1-ait vs. 4-ait) in improving aerobic capacity, cardiovascular function, skeletal muscle contractile function, skeletal muscle energy metabolism, left ventricle systolic and diastolic function at rest and right ventricular function. the investigators hypothesized that aerobic interval training would reverse features of the metabolic syndrome more than traditional training.

this study describes a randomized multicenter clinical trial designed to test the hypothesis that a 16-week program, with one year follow up of vigorously exercise defined from today's guidelines (performed as 4-ait (4x4min aerobe interval training)) yields larger beneficial effects in reducing risk factors constituting the metabolic syndrome than continuously moderate intensity exercise (cme) defined from today's guidelines. furthermore, the importance of the amount of aerobic interval training remains unclear and it is unknown how little "one can get away with" and still obtain substantial beneficial cardiovascular effects. therefore, the investigators will also determine whether one bout of aerobe interval training (ait) - 1-ait = 1x4min aerobe interval training, can give beneficial effects compared to 4-ait and cme. evaluation criteria are risk factors constituting metabolic syndrome, aerobic capacity measured as peak oxygen uptake and compliance to intervention. assessments will be made before and after the 16-week program, and at six month, and 1 and 3 years follow-up. according to estimates based on data from previously studies, 3, 4 a total number of 465 patients randomized 1:1:1 to the three interventions gives 80% power to detect an effect of 4-ait compared to 1-ait/cme of 51% recovery versus 37% recovery from metabolic syndrome at the 5% significance level.

Eligibility criteria:
inclusion criteria: * metabolic syndrome defined according to the idf-criteria exclusion criteria: * unstable angina * recent cardiac infarction (4weeks) * uncompensated heart failure * severe valvular illness * pulmonary disease * uncontrolled hypertension * kidney failure * orthopedic/neurological limitations * cardiomyopathy * planned operations during the research period * reluctant to sign the consent form * drug or alcohol abuse * participants in a parallel study

Keywords: exercise training exercise therapy physical fitness risk factors
tme alteration in her2 positive breast cancer

Conditions: Breast Cancer; HER2-positive Breast Cancer; Chemotherapy Effect

Summary: evaluate for changes in the tumor microenvironment before/during neoadjuvant chemotherapy and after treatment in patients diagnosed with her2-positive advanced breast cancer and receiving neoadjuvant cancer therapy and surgery for curative purposes.


Eligibility criteria:
inclusion criteria i. adult patients over 18 years of age ii. patients undergoing curative treatment including neoadjuvant chemotherapy after confirmation of breast cancer without distant metastases iii. clinical t stage ii-iv patients iv. her2 positive breast cancer patients exclusion criteria if you have other comorbidities that, according to the researcher's judgment, may affect the results of the study
safety, tolerability, pharmacokinetics and pharmacodynamics of multiple rising oral doses of bi 135585 xx in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of this study is to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of bi 135585 xx following multiple dose administration over 14 days


Eligibility criteria:
inclusion criteria: 1. male and postmenopausal or surgically sterilised female patients with an established diagnosis of type 2 diabetes mellitus prior to informed consent 2. antidiabetic treatment with diet and exercise alone or with not more than one oral hypoglycaemic drug except glitazones, glucagon-like peptide 1 (glp-1) analogues or dipeptidyl-peptidase 4 (dpp-4) inhibitors. 3. antidiabetic treatment unchanged for 12 weeks prior to informed consent 4. glycosylated haemoglobin a1 (hba1c) ≤ 8.5% at screening 5. age ≥ 20 and age ≤ 70 years 6. bmi ≥ 25 and bmi ≤ 40 kg/m2 (body mass index) 7. signed and dated written informed consent prior to admission to the study in accordance with gcp and the local legislation. exclusion criteria 1. any finding of the medical examination (including bp, pr and ecg) deviating from normal and of not acceptable clinical relevance 2. myocardial infarction, stroke or transient ischemic attack within 6 months prior to informed consent 3. gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes, hyperlipidaemia or medically treated hypertension 4. gastrointestinal tract surgery that might affect absorption and elimination of drugs 5. diseases of the central nerve system (such as epilepsy) or psychiatric disorders or relevant neurological disorders besides polyneuropathy 6. chronic or relevant acute infections (e.g. hiv, hepatitis) 7. history of allergy/hypersensitivity (including allergy to drug or its excipients) that are deemed relevant to subject's safety or the trial by the investigator 8. intake of drugs with a long half-life (\> 24 hours) within one month prior to administration of the trial drug except for allowed co-medication 9. treatment with glitazones, glp-1 analogues, insulin, dpp-4 inhibitors, systemic or inhaled glucocorticoids, or anti-obesity drugs (e.g. orlistat) within 12 weeks prior to informed consent 10. sensitive cyp3a4 substrates (e.g. simvastatin, lovastatin, verapamil, budesonide, buspirone, eplerenone , eletriptan, felodipine, fluticasone, midazolam, saquinavir, sildenafil, vardenafil) or cyp3a4 substrates with narrow therapeutic range (e.g. cyclosporine, ergotamine, pimozide, quinidine, sirolimus, tacrolimus, terfenadine) or drugs that prolong the qt/qtc interval (based on the knowledge at the time of protocol preparation) within 10 days prior to first administration of the trial drug 11. other exclusion criteria apply.
impact of circadian rhythm on the spread of circulating tumor cells in lung cancer patients

Conditions: Lung Cancer

Summary: this is a prospective pilot study designed to demonstrate the impact of circadian rhythm on the spread of circulating tumor cells (ctcs) in patients with non- small cell lung cancer - nsclc. 27 patients will be included in the study and will be followed for 12 months. for each included patient, blood samples will be collected before the anticancer treatment initiation.


Eligibility criteria:
inclusion criteria: 1. patient with histologically confirmed advanced nsclc (inoperable stage 3 or 4) 2. patient aged ≥ 18 years 3. life expectancy \> 3 months 4. patient naïve to treatment for nsclc 5. patient hospitalized at least one night for initiation of specific treatment (chemotherapy, radiotherapy, surgery, other...) 6. patient with no other active cancer. cancer history accepted if more than 3 years old and considered cured. 7. patient affiliated to a social security scheme in france. 8. patient having signed informed consent prior to inclusion in the study and prior to any specific study procedure. exclusion criteria: 1. small-cell cancer or cancer with a majority small-cell contingent 2. patient previously treated for nsclc 3. outpatient 4. patient with active pathology such as sepsis or uncontrolled inflammatory syndrome 5. any pathology contraindicating the sample collection procedures required by the study. 6. pregnant or breast-feeding women. 7. any psychological, family, geographical or sociological condition that makes it impossible to comply with the medical follow-up and/or procedures stipulated in the study protocol. 8. patients deprived of their liberty or under legal protection (guardianship, legal protection).

Keywords: circadian rhythm circulating tumor cells ctc cellsearch parsortix
stereotactic radiation therapy in treating patients with liver metastases

Conditions: Metastatic Cancer

Summary: rationale: stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. purpose: this phase i trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with liver metastases.

objectives: * to identify the maximum tolerated dose of stereotactic radiation therapy in patients with hepatic metastases. * to determine the toxicity and adverse events profile of this patient population. * to examine patient response, treatment effect on blood chemistry, and hematology values and patient quality-of-life in this patient population. outline: patients are stratified according to stereotactic radiotherapy level (1 vs 2 vs 3) and the number of liver lesions present (1-2 vs 3-5 vs \> 5). patients undergo percutaneous placement of metallic fiducial markers within the liver for stereotactic targeting and planning. patients then undergo 1 fraction of stereotactic radiotherapy within 1 week of the marker placement. patients complete brief pain inventory and brief fatigue inventory questionnaires to assess quality of life at weeks 2, 4, 6, 8 and months 3, 6, and 9 after completion of study treatment. after completion of study treatment, patients are followed for at least 8 weeks.

Eligibility criteria:
disease characteristics: * metastatic liver lesion ≤ 5 cm in dimension * willing and able to undergo percutaneous placement of localization seeds patient characteristics: * ecog performance status 0-1 * life expectancy ≥ 12 weeks * platelet count ≥ 75,000/µl * hemoglobin ≥ 9 g/dl * anc ≥ 1,500/ml * total bilirubin ≤ 1.5 x upper limit of normal (uln) * ast ≤ 3 x uln * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * able to complete questionnaires alone or with assistance * no medical, social, or economic circumstance, that is likely to prevent adherence with the protocol prior concurrent therapy: * no prior radiation therapy to the liver * no chemotherapy ≤ 4 weeks prior to registration * able to safely go without chemotherapy for 4 weeks after stereotactic radiotherapy (e.g., patients must not have or need chemotherapy in the 8 weeks \[4 weeks prior to and 4 weeks after registration\] surrounding stereotactic radiotherapy

Keywords: liver metastases
assessment of natural killer cells in unexplained recurrent pregnancy loss

Conditions: Female; Recurrent Miscarriage; Unexplained Pregnancy Loss

Summary: to assess natural killer cells frequency and activation in cases of unexplained recurrent abortion in comparison to fertile cases * 2. . to study the expression of stimulatory receptors of natural killer cell. * 3-to study the expression of inhibitory receptors of natural killer cell.

nk-cell functioning is controlled by a wide range of receptors that are expressed on the cell surface. these receptors are either inhibitory or activating in nature. the family of inhibitory receptors consists of the killer immunoglobulin-like receptors (kir) or ig-like receptors (cd158), the c type lectin receptors (cd94-nkg2a) and leukocyte inhibitory receptors (lir1, lair-1). activating receptors are the natural cytotoxic receptors (nkp46, nkp44), c type lectin receptors (nkg2d, cd94-nkg2c), and ig-like receptors (2b4). a particular nk cell typically expresses two to four inhibitory receptors in addition to an array of activation receptors. the killing by nk cells is mediated through several activating nk receptors. among these are nkg2d and the three natural cytotoxicity receptors (ncrs), nkp30, nkp44, and nkp46 (yang et al., 2000) osne of the natural cytotoxicity receptors (ncrs) nkp46, , is a unique marker that functions in nk cell cytotoxicity and cytokine production. expression of nkp46 on nk cells is lower in women with recurrent pregnancy loss, so evaluation of nkp46 on peripheral blood nk cells may provide a means of screening for reproductive abnormalities (fukui et al., 2015). during pregnancy, decidual nk cells comprise ∼70-80% of the decidual lymphocytes and are considered a special nk subset that does not exert cytolytic functions against trophoblast cells and has generally reduced cytotoxicity (hanna and mandelboim, 2007). these cells express activating nk receptors, including all the ncrs and nkg2d. however, instead of triggering cytotoxicity, these receptors act to stimulate secretion of cytokines and angiogenic factors, which are essential for trophoblast invasion and vascular modifications (hanna et al., 2006). one study reported that pnk cell levels show changes in decidual nk cell levels (park et al., 2010). whereas some other reports have shown that the assessment of peripheral blood nk cells would not

Eligibility criteria:
inclusion criteria: * 1.age less than 40 years. 2.history of two or more spontaneous miscarriages . exclusion criteria: * 1. age more than 35 years. 2. women with elevated level of tsh above (2.5 miu/ml) or prolactin above( 19.5 ng/ml)and uncontrolled dm. 3. women with autoimmune disorder (antiphospholipid antibody syndrome)with la1/la2 ratio more than( 1.2). 4.women receiving oral contraceptive pills.

Keywords: nk ;natural killer cells